Panels › Orthopedic › Product code HWC · Class 2
Screw, Fixation, Bone
Regulation 888.3040
22510(k)s in 12 months (1,070 all time)
7recalls in 12 months (389 all time)
359recalls that name a 510(k)
Top companies in HWC
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer, Inc. | 12 | 50 |
| Biomet, Inc. | 24 | 27 |
| Arthrex, Inc. | 47 | 1 |
| Acumed, LLC | 5 | 35 |
| Depuy Mitek, A Johnson & Johnson Co. | 13 | 21 |
| Synthes (Usa) | 31 | 3 |
| Smith & Nephew, Inc. | 27 | 6 |
| Smith & Nephew Inc., Endoscopy Division | 1 | 30 |
| Wrightmedicaltechnologyinc | 31 | 0 |
| Stryker Howmedica Osteonics Corp. | 0 | 30 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 29, 2011 | K111908 | BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM Biomet Microfixation, Inc. | HWC |
| Oct 20, 2011 | K112737 | TIGER HEADLESS CANNULATED SCREWS Trilliant Surgical, Ltd. | HWC |
| Oct 11, 2011 | K111994 | SMITH & NEPHEW CANNULATED SCREWS AND WASHERS Smith & Nephew, Inc. | HWC |
| Oct 7, 2011 | K112772 | ORTHOLOC(TM) BONE SCREWS Wrightmedicaltechnologyinc | HWC |
| Oct 5, 2011 | K111447 | ZIMMER PERIARTICULAR SCREWS Zimmer, Inc. | HWC |
| Sep 2, 2011 | K112237 | MICROSUTURE ANCHORS Arthrex, Inc. | HWC |
| Aug 29, 2011 | K111608 | SLIC SCREW REPAIR SYSTEM Acumed, LLC | HWC |
| Aug 19, 2011 | K111799 | NUGAIT(TM) SUBTALAR IMPLANT SYSTEM Ascension Orthopedic | HWC |
| Aug 9, 2011 | K111265 | METASURG SUBTALAR IMPLANT Metasurg | HWC |
| Jul 28, 2011 | K111000 | PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR Parcus Medical, LLC | HWC |
| Jul 28, 2011 | K102528 | N-FORCE FIXATION SYSTEM Innovision, Inc. | HWC |
| Jul 25, 2011 | K110592 | 3.7MM/5.0MM DYNAMIC LOCKING SCREW Synthes USA | HWC |
| Jul 21, 2011 | K111536 | METASURG DIGIFUSE IMPLANT Metasurg | HWC |
| Jul 20, 2011 | K111316 | AAP CANNULATED SCREWS Aap Implantate AG, DE | HWC |
| Jul 12, 2011 | K110538 | PRO FIXATION SYSTEM Synovis Orthopedic & Woundcare | HWC |
| Jun 2, 2011 | K110658 | APTUS CANNULATED COMPRESSION SCREWS Medartis AG | HWC |
| May 24, 2011 | K111230 | SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW Synthes (USA) Products, LLC | HWC |
| May 17, 2011 | K111001 | STERILE STORM (R) OPERATING KIT Intelligent Orthopaedics, Ltd., GB | HWC |
| May 4, 2011 | K102324 | ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM Wrightmedicaltechnologyinc | HWC |
| Apr 11, 2011 | K110763 | LATARJET CORTICAL SCREW SET T.A.G. Medical Products Corporation, Ltd. | HWC |
| Mar 18, 2011 | K103705 | LOW PROFILE SCREWS Arthrex, Inc. | HWC |
| Mar 17, 2011 | K110445 | FLEXFUSION (TM) FIXATION IMPLANT Nextremity Solutions, LLC | HWC |
| Mar 11, 2011 | K103712 | GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD Depuy Mitek, A Johnson & Johnson Company | HWC |
| Feb 8, 2011 | K103183 | TRILLIANT SURGICAL SUBTALAR IMPLANT Trilliant Surgical, Ltd. | HWC |
| Jan 7, 2011 | K102298 | TRANSTEND BR ANCHOR W/ ORTHOCORD, TRANSTEND TI ANCHOR W/ORTHOCORD, TRANSTEND PEEK ANCHOR W/ORTHOCORD, HEALIX TRANSTEND Depuy Mitek, A Johnson & Johnson Company | HWC |
| Dec 21, 2010 | K102410 | MATRYX INTERFERENCE SCREW (5.0-6.5MM) Conmed Linvatec | HWC |
| Nov 23, 2010 | K102343 | EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM Emerge Medical | HWC |
| Nov 23, 2010 | K100721 | LOCKING BONE SCREW MODEL HCQ04, HCZ04 Changzhou Orthmar Medical Instrument Co., Ltd., CN | HWC |
| Nov 22, 2010 | K093055 | CSTS SCREW Orthopro, LLC | HWC |
| Nov 15, 2010 | K102326 | PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR Parcus Medical, LLC | HWC |
| Nov 10, 2010 | K102162 | PARCUS PEEK CF PUSH-IN SUTURE ANCHOR Parcus Medical, LLC | HWC |
| Nov 8, 2010 | K101808 | SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER Medshape Solutions | HWC |
| Oct 20, 2010 | K102903 | PIONEER CANNULATED SCREW SYSTEM Pioneer Surgical Technology, Inc. | HWC |
| Oct 12, 2010 | K101700 | IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM Extremity Medical, LLC | HWC |
| Sep 10, 2010 | K101696 | MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM Zimmer, Inc. | HWC |
| Jul 23, 2010 | K101165 | PRO-TOE VO HAMMERTOW IMPLANT SYSTEM Wrightmedicaltechnologyinc | HWC |
| Jul 15, 2010 | K101254 | NEWFIX SCREW, WIRE AND PIN FIXARION SYSTEM Tecnologia Y Diseno Industrial, S.A DE C.V | HWC |
| Jun 24, 2010 | K100359 | DARCO HEADED CANNULATED SCREW Wrightmedicaltechnologyinc | HWC |
| Jun 23, 2010 | K093078 | UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS Bonutti Research, Inc. | HWC |
| Jun 3, 2010 | K101030 | MODIFICATION TO HBS HEADLESS BONE SCREW Biopro, Inc. | HWC |
| May 19, 2010 | K093820 | SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 Memometal Technologies, FR | HWC |
| May 4, 2010 | K100325 | PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES Smith & Nephew, Inc. | HWC |
| Apr 28, 2010 | K093770 | EXTREMITY MEDICAL SCREW SYSTEM Extremity Medical, LLC | HWC |
| Mar 19, 2010 | K100457 | OPUS SPEEDSCREW SYSTEM Arthrocare Corp. | HWC |
| Mar 17, 2010 | K100532 | VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819 Depuy Mitek, A Johnson & Johnson Company | HWC |
| Mar 17, 2010 | K093676 | OMNITECH LARGE, TRIMED COMPRESSION SCREW TriMed, Inc. | HWC |
| Jan 19, 2010 | K092754 | SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061 Small Bone Innovations, Inc. | HWC |
| Jan 11, 2010 | K092909 | SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE) Synthes (Usa) | HWC |
| Dec 16, 2009 | K091118 | FOOT AND HAND MOTION SYSTEM Newclip Technics | HWC |
| Nov 13, 2009 | K091686 | LEFORTE NEUROSYSTEM BONE SCREW Jeil Medical Corporation | HWC |
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